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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device radioimmunoassay, dehydroepiandrosterone (free and sulfate)
Product CodeJKC
Regulation Number 862.1245
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2021 1 1
2022 2 2
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 8 8
Low Test Results 2 2
Leak/Splash 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 2 2
No Code Available 1 1

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